MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION; BONE PLATE

Model Number	447.051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020 thetwo (2) bending template holes for reconstruction plates, one (1) bending template for matrixrib locking plates, one (1) screwdriver blade hexagonal self retain plusdrive and two (2) titanium locking plate holes adaption were found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This report is for one 2.0mm ti mini locking plate 20 holes/adaption.This is report 5 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part number: 447.051 lot number: 7372516 part manufacture date: 26-apr-2013 manufacturing location: elmira part expiration date: n/a nonconformance noted: n/a dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.0mm ti mini locking plate 20 holes/adaption product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: visual inspection performed at customer quality (cq) identified that implant broke at the juncture between the 16th & 17th hole section (plate from 17th hole onward was not returned).The break is jagged and oblique.A device failure was identified.Dimensional inspection: measured dimensions: conforming document specification the following documents were reviewed as part of this investigation: - 2.0mm mlp adaptation plate 20 hole, mini based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9639841
• Report Number: 2939274-2020-00495
• Device Sequence Number: 2913640
• Product Code: JEY
• UDI-Device Identifier: 10887587052618
• UDI-Public: (01)10887587052618
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 447.051
• Device Catalogue Number: 447.051
• Device Lot Number: 7372516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1